Butterfly Medical Secures EU MDR Certification for Minimally Invasive BPH Implant

Israel-based medical device manufacturer Butterfly Medical has announced that its Butterfly Prostatic Retraction Device has secured European Union Medical Device Regulation certification. The regulatory milestone follows the conclusion of a pivotal clinical study that evaluated 244 patients suffering from lower urinary tract symptoms associated with benign prostatic hyperplasia, commonly known as BPH.

An Intermediate Alternative for BPH Management

Benign prostatic hyperplasia involves the non-cancerous enlargement of the prostate gland, which can obstruct the urethra and cause significant urinary difficulties in aging men. The newly certified Butterfly Prostatic Retraction Device is an anatomically contoured implant designed to position prostate tissue in a way that facilitates natural urine flow.

Positioned as an intermediate clinical option situated between daily drug regimens and conventional surgical operations, the retraction system aims to improve patient outcomes without ablating, excising, or burning prostate tissue. Furthermore, the developer notes that healthcare facilities can deploy the technology without purchasing specialised capital equipment.

Insights From Clinical Leadership

Butterfly Medical CEO Patrick MacCarthy described the European certification as a major milestone for the organisation. According to MacCarthy, the regulatory achievement reflects years of dedicated clinical studies and quality system development, reinforcing the company commitment to meeting rigorous regulatory standards across international markets.

Dr James Ulchaker, chief medical officer at Butterfly Medical and an emeritus urologist at the Cleveland Clinic, emphasised the importance of expanding personalized treatment options for patients. Dr Ulchaker stated that BPH affects men differently and that patients deserve treatment choices addressing their individual needs and preferences, including the desire to avoid tissue ablation or long-term medication use.

Recognised Clinical Risks and Adverse Events

As observed across various therapeutic interventions designed to treat benign prostatic hyperplasia, the Butterfly procedure carries several recognised clinical risks and potential complications. Documented adverse events associated with the procedure include:

• Bleeding and localized urinary discomfort
• Increased urinary frequency and urgency
• Potential requirement for surgical removal of the prosthesis in specific cases

The manufacturer designed the minimally invasive device to relieve lower urinary tract symptoms and enhance patients overall quality of life, offering an alternative to pharmaceutical therapies and invasive surgical procedures.

Regulatory Status and Future Outlook

In parallel with its successful European regulatory pathway, Butterfly Medical has submitted a Premarket Approval application to the US Food and Drug Administration. Although the retraction device has obtained CE Mark certification under the EU MDR framework, federal regulators have not yet cleared the technology for commercial use or distribution in the United States.

The recent regulatory advancement follows corporate financial developments, including a Series C funding round in May 2026 where Butterfly Medical raised $21m to support the ongoing development and potential commercialisation of its minimally invasive BPH solution.